Product Development Engineer II

New Product Development Engineer II – Biomerics

Join the Biomerics team as a New Product Development Engineer II and help design and develop catheters from concept to production that exceed customer expectations.

Biomerics is a world‑class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures, focusing on next‑generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

• Execute design, development, and validation activities through the product life cycle for development products in accordance with project scope.
• Deliver manufacturable products using the Design Control process to create cost‑effective and efficient solutions.
• Contribute to deliverables utilizing the Design Control process in accordance with MDR, ISO, and EN standards.
• Understand customer specifications/requirements and translate them into clear, concise performance and functional requirements.
• Create and conduct engineering evaluations, characterization, design of experiments (DOE), bench testing, or other verification activities to improve and confirm design capability.
• Train and guide development technicians/operators in prototyping, testing, and process development.
• Execute document change requests and train personnel on updated documentation.
• Design, procure, install, qualify, document, and train new tooling/fixturing.
• Evaluate and implement new technologies and ideas for products.
• Use statistical tools to analyze data and make development decisions to improve process capability.
• Develop/refine manufacturing procedures, test/inspection plans to ensure quality requirements are met and manufacturing risks are mitigated.

• Preferred Bachelor’s Degree in Engineering with 2–5 years of medical device experience or a combination of work history in the medical device or relevant field totaling 5–8 years.
• Good understanding of design controls, process development, and characterization of test methods for verification and validation of components, sub‑systems, and assemblies.
• Proficient in 3D modeling (Solid Works preferred) and working knowledge of drafting specifications such as GD&T.
• Complex problem‑solving skills, including use of statistical techniques such as DOE, ANOVA, t‑tests, normality, and process capability metrics.
• Strong technical writing skills.
• Strong internal and external communication, presentation, follow‑through, and organizational skills; able to work effectively with coworkers at all levels.

• Competitive compensation and benefits package
• Opportunities for professional growth and development
• Collaborative and inclusive work environment
• Impactful work that directly improves lives
• Medical/Dental/Vision Insurance, Short‑Term Disability, Long‑Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401(k)

Salary: $95,000‑$105,000

Mid‑Senior level

Full‑time

Engineering and Information Technology

Medical Equipment Manufacturing

Biomerics is an equal opportunity employer committed to a diverse workplace.